Boehringer Ingelheim and Lilly initiate MARLINA™ clinical trial to evaluate
use of Trajenta® (linagliptin) in patients with type 2 diabetes and
INGELHEIM, Germany -- March 19, 2013
For Non-U.S. and Non-U.K. Media
Boehringer Ingelheim and Eli Lilly and Company announced today the initiation
of a Phase IIIb trial to evaluate the glycaemic efficacy and safety of
linagliptin in type 2 diabetes patients with prevalent albuminuria, and
urinary albumin-to-creatinine (UACR) ratio 30-3000 mg/g creatinine, in
addition to current standard therapy for diabetic nephropathy. The name of the
clinical trial is MARLINA^™*.
“With linagliptin, no dose adjustment is required even for patients with
declining renal function”, said Professor Per-Henrik Groop, Professor of
Nephrology, and Chief Physician at the Division of Nephrology, Helsinki
University Central Hospital, Helsinki, Finland and Principal Investigator of
the MARLINA^™ trial. “What is of particular interest is that this study will
evaluate the glycaemic efficacy and safety of linagliptin therapy in patients
with type 2 diabetes whose kidneys are excreting significant amounts of
albumin, a marker of both, kidney damage as well as an overall increased
The primary endpoint of MARLINA^™ is the change from baseline in HbA1c after
24 weeks of treatment. The study is expected to complete in 2014.
“The initiation of this new trial reinforces our ongoing commitment to the
field of type 2 diabetes” said Professor Klaus Dugi, Corporate Senior Vice
President Medicine, Boehringer Ingelheim. “It is important to find more
treatment options, especially for those patients who are at risk of renal and
cardiovascular disease and who have limited choices of treatment".
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and
other regulatory authorities worldwide approved linagliptin for the treatment
of adult patients with Type 2 Diabetes as monotherapy or in combination with
metformin, metformin plus sulphonylurea, and as add-on therapy to insulin. In
the US, linagliptin is also approved for use in this population with
sulphonylurea and with pioglitazone.^1 With linagliptin, no dose adjustment is
required regardless of declining renal function or hepatic impairment.^1,2
^* MARLINA^™ (efficacy, safety & Modification of Albuminuria in type 2
diabetes subjects with Renal disease with LINAgliptin).
Please click on the link below for ‘Notes to Editors’ and ‘References’:
Launch and Established Products CVM
Boehringer Ingelheim GmbH
Phone: +49 (6132) 77-2091
Phone: (317) 651-9116
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